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Phase 3 N=626 Randomized Double-blind Treatment

The Efficacy of a Toothpaste to Reduce Sensitivity

Dentin Hypersensitivity

Enrolled (actual)
626
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcome: Primary: Hypersensitivity Tactile(Yeaple Probe) — 19.81; 13.94 units on a scale — p=0.05

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Triclosan, Silicon dioxide, fluoride (Drug); Triclosan, fluoride (Drug)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
Colgate Palmolive
Primary completion
Dec 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Hypersensitivity Tactile(Yeaple Probe)
19.81; 13.94 0.05
PRIMARY
Hypersensitivity Tactile (Yeaple Probe)
31.90; 17.28 0.05
SECONDARY
Air Blast Hypersensitivity (4 Week)
1.61; 2.18 0.05
SECONDARY
Air Blast Hypersensitivity (8 Week)
0.89; 1.80 0.05

Summary

Hypersensitivity

Eligibility Criteria

Inclusion Criteria

  • Male and female subjects, ages: 12 years or older.
  • Availability for the eight-week duration of the study.
  • Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
  • Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force.
  • Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
  • Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study.
  • Good general health with no known allergies to products being tested.
  • Use of a non-desensitizing dentifrice for one month prior to entry into the study.
  • Signed Informed Consent Form.

Exclusion Criteria

  • Gross oral pathology, chronic disease, or history of allergy to test products.
  • Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
  • Sensitive teeth with a mobility greater than one.
  • Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
  • Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics.
  • Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month.
  • Current participation in any other clinical study.
  • Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients.
  • Medical condition which prohibits not eating/drinking for 4 hours.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00763269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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